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EP3065675B1 - Dispositif endoluminal - Google Patents

Dispositif endoluminal Download PDF

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Publication number
EP3065675B1
EP3065675B1 EP14805717.7A EP14805717A EP3065675B1 EP 3065675 B1 EP3065675 B1 EP 3065675B1 EP 14805717 A EP14805717 A EP 14805717A EP 3065675 B1 EP3065675 B1 EP 3065675B1
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EP
European Patent Office
Prior art keywords
wire
distal end
region
end region
endoluminal device
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
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EP14805717.7A
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German (de)
English (en)
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EP3065675A1 (fr
Inventor
Kevin Walsh
Gary TRENDEL
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Boston Scientific Scimed Inc
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Boston Scientific Scimed Inc
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Priority to EP22193387.2A priority Critical patent/EP4147680A1/fr
Publication of EP3065675A1 publication Critical patent/EP3065675A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/041—Bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/044—Oesophagi or esophagi or gullets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045—Stomach, intestines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/06—Vascular grafts; stents

Definitions

  • the present disclosure relates to implantable endoluminal devices comprising a stent for use in the treatment of various body lumens.
  • devices of the present disclosure are particularly suited to be advanced from the duodenum and into pancreatic duct so as to prevent narrowing of the duct and/or to restore its patency.
  • Pancreatic endotherapy has been used for years for treatment of several types of pancreatic disorders including but not limited to chronic pancreatitis, idiopathic acute recurrent pancreatitis, and many such others.
  • pancreas Normally, inside the human body the pancreas is connected to the duodenum via the pancreatic duct.
  • the pancreatic duct extends into the duodenum at the major duodenal papilla (adjacent the Ampulla of Vater of the bile duct).
  • the pancreatic duct delivers to the duodenum pancreatic fluids required for metabolism.
  • pancreatic tissues may swell or increase abnormally thereby constricting the pancreatic duct and obstructing flow of pancreatic fluids into the duodenum. Such obstructions could lead to various complications including those arising from the accumulation of pancreatic fluids inside the pancreatic tissue or the pancreatic duct.
  • an endoluminal device including a stent or other support structure may be used for treatment of the obstructed pancreatic duct.
  • the endoluminal device provides an outwardly-directed radial force that opens the constriction of the pancreatic duct thereby allowing pancreatic fluid to flow into the duodenum.
  • stents within the pancreatic duct have been performed for several years. Experience has shown that in some cases the pancreatic duct suffers irritation, inflammation, or other complications as a result of the stent's advancement through the duct. A need therefore exists to provide an endoluminal device for use in the pancreatic duct that minimizes or eliminates irritation to the duct tissue during advancement and/or deployment of the device.
  • a stent is provided with a "soft" distal end or tip which minimizes the forces acting on the pancreatic duct as the endoluminal device is advanced therethrough in order to minimize or eliminate irritation to the duct.
  • the present disclosure describes implantable endoluminal devices for use in body lumens, with particular configurations suitable for the pancreatic duct.
  • the term "example” does not necessarily imply that what follows is not encompassed by the independent claim 1.
  • the invention is directed to an endoluminal device including a stent.
  • Such devices are provided with a reduced diameter state for advancement into the pancreatic duct and are expandable to an expanded state for secure placement therein.
  • the stent comprises a self-expandable, braided wire, framework.
  • the device further includes a sleeve.
  • the stent and the sleeve are coextensive along the entire longitudinal length of the endoluminal device. In some embodiments, the sleeve forms at least a portion of the entire outer surface of the cridoluminal device.
  • a distal end region of the stent is configured with a "soft" tip. The term “soft” refers to the greater flexibility (i.e., relatively reduced force required for radial compression) of the distal end region compared to the main body of the stent. This greater flexibility of the distal end region (compared to the main body of the stent) helps to reduce the radial force acting on the pancreatic duct (and thus minimize irritation thereto) as the endoluminal device is advanced therethrough.
  • an endoluminal device includes a stent, the device having a proximal end region, a distal end region, and a medial region extending therebetween; the distal end region of the device being more flexible than the medial region such that the radial compressive force at a reduced diameter configuration is less at the distal end than the medial region (e.g., radial compressive force at the distal end less than two-thirds of that at the medial region).
  • an endoluminal device includes a stent (e.g., a stent and a sleeve, etc.), the device having a proximal end region, a distal end region, and a medial region extending therebetween; the distal end region of the device being more flexible than the medial region such that, to radially compress the device to a reduced diameter configuration, the radial compression force required at the distal end region is less than the radial compression force required at the medial region.
  • a stent e.g., a stent and a sleeve, etc.
  • the distal end region of the device is more flexible than the medial region such that, to radially compress the device to a reduced diameter configuration, the radial compression force required at the distal end region is less than about two-thirds of the radial compression force required at the medial region.
  • the stent is constructed from at least one wire, the at least one wire forming a medial region braid pattern in the medial region wherein the at least one wire defines a medial region braid angle (e.g., angle ⁇ in, e.g., Fig. 4 ; an intersection angle that opens toward the proximal end and is located in the medial region) and the at least one wire forming a distal end region braid pattern in the distal end region wherein the at least one wire defines a distal end region braid angle (e.g., angle ⁇ ' in Fig. 4 or angle ⁇ " in Fig.
  • a medial region braid angle e.g., angle ⁇ in, e.g., Fig. 4 ; an intersection angle that opens toward the proximal end and is located in the medial region
  • the at least one wire forming a distal end region braid pattern in the distal end region wherein the at least one wire defines a distal end region braid angle (e.g., angle ⁇ ' in
  • the distal end region braid angle is a first distal end region braid angle
  • the at least one wire also defines a second distal region braid angle located more distal than the first distal end region braid angle and having a value less than that of the first distal region braid angle (see, e.g., proximal-facing angle between straight portions 22).
  • the at least one wire also defines a third distal region braid angle located more distal than the second distal end region braid angle and having a value greater than that of the second distal end region braid angle.
  • the median region braid angle is greater than 90 degrees (e.g., greater than 95 degrees, from 95 degrees to 115 degrees, etc.).
  • the distal end region of the device includes a plurality of loops formed from the at least one wire, each loop having a length in the axial direction and a width in the circumferential direction, wherein the length is greater than the width.
  • Each loop may include a joining region.
  • each loop may be formed from the at least one wire that includes a first wire and a second wire joined at a joining region.
  • each loop is interbraided with two adjacent loops.
  • each loop contacts a single loop in each circumferential direction.
  • each loop is defined by a straight portion that terminates at a distal bend region.
  • the at least one wire includes a first wire that extends in a first helical direction in the medial region, transitions into a straight portion that extends in an axial direction in the distal end region, and further transitions into the first helical direction distal of the straight portion.
  • the first wire further transitions from a first helical direction to a second helical direction, via a bend at the end of the device, the at least one wire further comprises a second wire that extends in the second helical direction and joins the first wire at a joining region.
  • the at least one wire includes a first wire that extends in a first helical direction in the medial region, transitions into a straight portion that extends in a generally axial direction in the distal end region, and further defines a first distal curve of about 90 degrees and a second distal curve of about 90 degrees.
  • the first wire further defines a first proximal curve of about 90 degrees, and a second proximal curve of about 90 degrees.
  • the at least one wire further comprises a second wire that extends in a second helical direction in the medial region, transitions into a straight portion that extends in a generally axial direction in the distal end region, and joins the first wire at a joining region.
  • the distal end region is flared and defines a distal opening that has a greater diameter than the medial region.
  • an endoluminal device includes a stent (e.g., a stent and a sleeve), the device having a proximal end region, a distal end region, and a medial region extending therebetween; the distal end region of the device being more flexible than the medial region; wherein the distal end region of the device comprises a plurality of loops formed from the at least one wire, wherein each loop is interbraided with two adjacent loops.
  • a stent e.g., a stent and a sleeve
  • an endoluminal device includes a stent (e.g., a stent and a sleeve, wherein the sleeve may be, e.g., a coating, covering, inner tube, outer tube, heat shrink tube, combination of one or more of these, etc.), the device having a proximal end region, a distal end region, and a medial region extending therebetween; the distal end region of the device being more flexible than the medial region; wherein the stent is constructed from at least one wire, wherein the at least one wire comprises a first wire that extends in a first helical direction in the medial region, transitions into a straight portion that extends in an axial direction in the distal end region, and further transitions into the first helical direction distal of the straight portion.
  • a stent e.g., a stent and a sleeve, wherein the sleeve may be, e.g., a coating,
  • the invention can be used in humans and used in non-human animals. This invention is suitable for use in the pancreas and for use in other organs and tissues. Although, illustrated embodiments refer to an endoluminal device being placed in the pancreatic duct, the inventive medical device can be used for performing a medical procedure in any body passageway including but not limited to gastrointestinal tract, the biliary tract, the urinary tract, reproductive tract, the respiratory tract, the arteries and veins.
  • One aspect of the inventive medical device is to expand or open a passageway to allow flow of materials or air inside the body of a patient
  • proximal and distal are used to indicate and differentiate the end regions of the endoluminal device being described (e.g. a proximal end of the device and a distal end of the device). While it is known that some physicians who regularly utilize pancreatic stents refer to the "distal end" of a pancreatic stent as being that end of the stent which is positioned in (or immediately adjacent to) the duodenum and the "proximal end” of the stent as being that end which is positioned within the pancreatic duct; as used herein however, the term “proximal” refers to an area or portion of the medical device or patient that is closest to the physician during a placement procedure.
  • distal refers to an area or portion that is farthest from the physician.
  • medial refers to an area or portion that is disposed between the distal end and the proximal end.
  • the length of the "medial" portion of an endoluminal device divided by the length of the endoluminal device is at least 0.20 (e.g., at least 0.40, at least 0.50, at least 0.60, at least 0.80) and might or might not be centrally located along the length of the endoluminal device.
  • Device 10 is comprised of a stent 12 and a sleeve 14.
  • Device 10 includes an enlarged or flaired proximal end region 20, a distal end region 40, and a medial region 30 extending therebetween.
  • Device 10 has an exterior surface 50 and an interior surface 60.
  • the interior surface 60 defines a passage or lumen 62 which extends between a proximal opening 22 at the proximal end of the device 10 and a distal opening 42 at the distal end of the device 10.
  • the distance between the proximal opening 22 and distal opening 42 defines the device length (L).
  • stents such as stent 12 shown, have a plurality of cells or openings along the length and circumference of the stent. These cells or openings are defined by a plurality of structural members. Structural members of a stent depend upon the construction of the stent and include for example, struts, connectors, and wires.
  • a stent may be constructed or formed from one piece of material (e.g., a wire, a filament, etc.) or may include a plurality of pieces of material (e.g., a plurality of wires and/or filaments, etc.).
  • a plurality of wires may include wires that are bent (e.g., at midpoint, etc.) and woven.
  • stent 12 includes spaces or openings 64 that are defined by wires 16, which form the stent 12.
  • the stent 12 is provided with a retrieval loop (not shown).
  • one or more of the loops 68 openings at an end of the stent which comprise the proximal end region 20 of the stent 12, function as a retrieval loop.
  • the retrieval loop is a means by which the endoluminal device 10, or a portion or portions thereof, can be repositioned or removed after implantation.
  • Non-limiting examples of suitable materials from which the stent 12 can be constructed from biocompatible materials including one or more polymers, one or more metals or combinations of polymer(s) and metal(s).
  • Polymers that may be used include polyester and polycarbonate copolymers.
  • suitable metals include, but are not limited to, titanium, tantalum, platinum, tungsten, gold and alloys of any of the above-mentioned metals.
  • suitable alloys include stainless steel, platinum-iridium alloys, cobalt-chromium alloys including Elgiloy and Phynox, MP35N alloy and nickel-titanium alloys, for example, Nitinol. It is within the scope of the invention for the stent 12 to be self-expandable, balloon expandable, or both balloon expandable and self-expandable.
  • stent 12 is made of shape memory materials, such as superelastic Nitinol, or may be made of materials which are plastically deformable.
  • shape memory materials the stent may be provided with a memorized shape and then deformed to a reduced diameter shape. The stent may restore itself to its memorized shape upon being heated to a transition temperature and/or having any restraints removed therefrom.
  • a shape memory material does not require heat after it is set the first time.
  • the stent 12, the delivery system (not shown) or other portion of the endoluminal device 10 may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc. In some examples, at least a portion of the endoluminal device 10 is at least partially radiopaque.
  • the stent 12 and/or the sleeve 14 include a therapeutic coating and/or a therapeutic substance delivery mechanism.
  • sleeve 14 is an elastic or conforming polymeric covering.
  • the sleeve 14 can be made of a material that is impermeable, semi-permeable, selectively permeable, permeable, and any combination thereof.
  • Materials that can be used to make the sleeve 14, or sleeve composition include but are not limited to, silicone, polystyrenepolyisobutylene-polystyrene triblock copolymer (SIBS), polyurethane, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), and any combination thereof.
  • a sleeve 14 may be applied to a stent 12 by any of a wide variety of methods (e.g., dipping, spraying, coating, wrapping, shrinking, adhering, bonding, friction fitting, etc.) and may be applied to the inside of a stent, the outside of a stent, or both the inside and outside of a stent.
  • methods e.g., dipping, spraying, coating, wrapping, shrinking, adhering, bonding, friction fitting, etc.
  • the stent 12 and sleeve 14 are coextensive along the entire longitudinal length of the endoluminal device 10.
  • the length of the stent 12 and the length of the sleeve 14 are the same length and equal to the length of the endoluminal device 10.
  • the stent 12 is disposed within the sleeve 14.
  • the stent 12 is disposed about (e.g., outside, around, circumscribing, surrounding, etc.) the sleeve 14.
  • the sleeve 14 When the sleeve 14 is disposed within or about the stent 12, the sleeve 14 covers the openings 64 of the stent 12 so that there are no openings in the wall of the endoluminal device 10. In some examples, selected regions or areas of the sleeve 14 define openings to allow branches of the pancreatic duct access to the lumen 62 when the endoluminal device 10 is placed therein. In some examples, the sleeve 14 forms at least a portion of the entire outer surface 50 of the endoluminal device 10. In other examples, the sleeve 14 forms at least a portion of the entire inner surface 60 of the endoluminal device 10. In still other examples, the stent 12 is sandwiched between multiple layers of sleeve material, of which the layers may or may not be of the same material and/or construction.
  • FIG. 2 an example of the endoluminal device 10 is depicted following deployment of the device into the pancreatic duct 100.
  • the distal end region 40 is extended well within the pancreatic duct 100.
  • the device 10 is positioned beyond the genu (bend) 112 of the duct or before it.
  • the flared proximal end region 20 remains within the duodenum 110, abutting the major duodenal papilla 114.
  • the pancreatic duct 100 defines a tortuous pathway through which the endoluminal device 10 must be advanced if it is to be positioned and deployed in the manner shown.
  • Embodiments of the present device 10 shown in FIGs. 3-9 provide the stent 12 with distal end regions 40 with improved flexibility and functional "softness" to minimize or eliminate such irritation.
  • FIG. 3 A first example of the stent 12 having an improved distal end region 40 is shown in FIG. 3 .
  • the distal end region includes a plurality of loops 68.
  • Each loop 68 is defined by a straight portion 22 of a stent wire 16, which extends from the braid pattern of the medial region 30 (in a first helical direction) into the loop 68.
  • Each straight portion 22 terminates at a distal bend region 24, which bends back from the straight portion 22 toward the medial region 30 of the stent in an approximately 180-degree arc.
  • each loop has a length in the axial direction that is greater than the loop's width in the circumferential direction.
  • the stent wire or wires 16 in the medial region 30 define a medial region braid angle ⁇ of greater than 90 degrees.
  • the term braid angle as used herein refers to the angle made by two wires, or sections of wires and form an angle that opens along the longitudinal axis (e.g., opening in a proximal direction) of the stent. In some examples, braid angle ⁇ is between 95 and 115 degrees.
  • the value of the braid angle a is reduced such that at least one (e.g., a plurality of, at least 50 percent of, all of, etc.) all of the braid angles within the distal end region, represented by ⁇ ', are less than ⁇ (e.g., before and/or after deployment).
  • the wire or wires 16 are bent back proximally in to engage an immediately adjacent wire 16 at a joining region 26 to define end loops 68.
  • the braid angles in the medial region 30 can be the same or different than the angles in the distal end region 40.
  • FIG. 5 Another example of the stent 12 is shown in FIG. 5 .
  • the wire or wires 16 define end loops 68 which have a "G" shape.
  • the braid angle ⁇ of the stent medial region 30 wire intersections e.g., between wire 16' extending in a first helical direction and wire 16" extending in a second helical direction
  • the loops 68 are formed by joining a straight portions 22 (e.g., extending in an axial direction) of a first wire 16' with an adjacent wire 16"
  • Wire 16" defines a first distal curve ⁇ " of about 90 degrees, a second distal curve ⁇ " of about 90 degrees, a first proximal curve ⁇ ′′′ of about 90 degrees, and a second proximal curve ⁇ of about 90 degrees.
  • the straight portion 22 of the first wire 16' and a straight portion 22 of the adjacent wire 16" are joined at a joining region 26.
  • FIG. 6 Yet another example of the stent 12 is shown in FIG. 6 .
  • the wire arrangement of the distal end region 40 is the same as that of the embodiment shown in FIG. 5 , but the distal end region 40 is flared such that the distal opening 42 has a diameter greater than the diameter of the lumen 62 of the medial region 30.
  • FIG. 7 An embodiment of the stent 12 according to the invention is shown in FIG. 7 .
  • the braid angles ⁇ of the medial region 30 once again transition to smaller braid angles ⁇ ' in the distal end region 40.
  • the wires 16 form the loops 68 (e.g., closed loops) with straight portions 22 and which terminate by bending a wire 16' back to join an adjacent wire 16" at a joining region 26.
  • the overlapping of the wire 16 is skipped between straight portions 22 to ensure that there is no contact between the straight portions 22 of adjacent loops 68.
  • each loop 68 is shown to overlap, contact, and be loosely linked to (e.g., interbraided with) a circumferentially adjacent loop 68 in each circumferential direction.
  • the extent of overlap of loops 68 is such that there is no contact between the straight portions 22.
  • the straight portions 22 are made to alternatingly overlap such as in the embodiment shown in FIG. 8 .
  • FIG. 8 In FIG.
  • wire 16' is shown to extend in a first helical direction (e.g., clockwise) in the medial region, transition into a straight portion that extends in a generally axial direction in the distal end region, transition into a second helical direction (e.g., counter clockwise) distal of the straight portion, and transition at the distal opening into the first helical direction (e.g., clockwise) via a distal bend region.
  • first helical direction e.g., clockwise
  • wire 16' is shown to extend in a first helical direction (e.g., clockwise) in the medial region, transition into a straight portion that extends in a generally axial direction in the distal end region (where it overlaps a straight portion 22 of a different wire at a second distal region braid angle that is less than the first distal region braid angle that is located proximal of the second distal region braid angle), transition back into the first helical direction (e.g., clockwise) distal of the straight portion (where it overlaps a wire extending in the second helical direction (e.g., counter clockwise) at a third distal region braid angle that is greater than the second distal region braid angle that is located proximal of the third distal region braid angle), and transition at the distal opening into a second helical direction (e.g., counter clockwise) via a distal bend region.
  • first helical direction e.g., clockwise
  • wire 16' is shown to extend in a first helical
  • the braid angles ⁇ of the medial region 30 transition to smaller braid angles ⁇ ' in the distal end region 40.
  • the geometry of the distal end region 40 is defined by one wire 16' continuing in accordance with a first defined helical path way of the stent body (e.g., medial region), while a second wire 16" transitions from a second defined helical path way of the stent body in the medial region 30 into a straight portion 22 that extends in a generally axial direction in the distal end region, and further transitions back into the first helical direction distal of the straight portion.
  • the wire 16" extends distally from the straight portion 22 whereupon it bends back proximally to join an adjacent wire 16' at a joining region 26.
  • Each of the various configurations of the distal end region 40 of the stent 12 shown in FIGs. 3-9 provide the endoluminal device 10 with improved distal end flexibility.
  • Providing the distal end of the device with improved flexibility reduces the forces that the device 10 applies against the bends within wall of the pancreatic duct as the device 10 is advanced therethrough.
  • the reduction in force function to "soften” the impact of the device 10 as it pushes against and around the walls of the duct.
  • irritation of the duct is reduced, which in turn minimizes both immediate and potentially long term complications to the patient.
  • FIG. 10 This "softness" as characterized above is depicted in the charts shown in FIGs. 10 and 11 .
  • test results of two examples of the endoluminal device 10 are shown.
  • the chart illustrates that normalized radial force (N) applied to the medial region 30 (STENT BODY) and the distal end region 40 (TIP) of devices 10 having a 3.5 mm reduced diameter and 4.5 mm reduced diameter respectively.
  • N normalized radial force
  • TIP distal end region 40
  • the amount of force necessary to reduce the distal end region 40 is ⁇ 33% less than the force required to reduce the medial region 30 of the device.
  • the force required to reduce the distal end region 40 is approximately two-thirds or less of the force required to radially compress the medial region 30.
  • the stent radial force results shown in FIGs. 10-13 were measured on an MSI R-Series Radial Expansion Force Testing Equipment (commercially available from Machine Solutions, Inc.
  • Radial expansion force testing may also be performed using equipment commercially available from Blockwise Engineering, LLC (Tempe, AZ) (see, for example, " Radial Force Testing Equipment,” Blockwise Engineering, LLC, Tempe, AZ, 2014, available online at http://www.blockwise.com/radialforce.htm , which is incorporated herein by reference).
  • FIG. 11 shows a similar comparison of devices 10 of different diameters, but here the devices were tested to determine the different radial force required to radially expand the devices.
  • the force required to radially expand the distal end region 40 TIP
  • the force required to expand the distal end region 40 is approximately two-thirds or less of the force required to radially expand the medial region 30.
  • endoluminal devices of the present disclosure may include a characteristic wherein, when reducing the diameter of the device, radial compression forces at the tip (e.g., the distal end region) are lower than the radial compression forces at the body portion (e.g., the medial region), as shown in FIG. 12 over a wide range of diameter changes.
  • endoluminal devices of the present disclosure may include a characteristic wherein, when increasing the diameter of the device, radial expansion forces at the tip (e.g., the distal end region) are lower than the radial expansion forces at the body portion (e.g., the medial region), as shown in FIG. 13 over a wide range of diameter changes.

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Claims (15)

  1. Dispositif endoluminal (10) comprenant un stent (12), le dispositif endoluminal (10) ayant une région d'extrémité proximale, une région d'extrémité distale (40) et une région moyenne (30) s'étendant entre elles; la région d'extrémité distale (40) du dispositif endoluminal (10) étant plus flexible que la région moyenne (30); où la région d'extrémité distale (40) du dispositif endoluminal (10) comprend une pluralité de boucles (68) formées à partir d'au moins un fil (16), où le fil (16) inclut des parties rectilignes (22) s'étendant dans une direction généralement axiale pour former les boucles (68), caractérisé en ce que chaque boucle (68) et deux boucles (68) adjacentes se chevauchent.
  2. Dispositif endoluminal selon la revendication 1, où chaque boucle (68) a une longueur dans la direction axiale et une largeur dans une direction circonférentielle, où la longueur est plus grande que la largeur.
  3. Dispositif endoluminal selon la revendication 1, où chaque boucle (68) et une boucle (68) adjacente de manière circonférentielle se chevauchent dans chaque direction circonférentielle.
  4. Dispositif endoluminal selon l'une quelconque des revendications 1-3, où le au moins un fil comprend un premier fil (16') qui s'étend dans une première direction hélicoïdale dans la région moyenne (30) et passe dans la partie rectiligne (22) qui s'étend dans une direction axiale dans la région d'extrémité distale (40).
  5. Dispositif endoluminal selon la revendication 4, où le premier fil (16') passe d'une direction axiale dans la région d'extrémité distale (40) à une seconde direction hélicoïdale distale de la partie rectiligne (22).
  6. Dispositif endoluminal selon la revendication 5, où le premier fil (16') passe de la seconde direction hélicoïdale à la première direction hélicoïdale par l'intermédiaire d'une région de flexion distale au niveau de la région d'extrémité distale (40) du dispositif endoluminal.
  7. Dispositif endoluminal selon la revendication 1, où chaque boucle formée à partir du au moins un fil comprend un premier fil (16') et un second fil (16'').
  8. Dispositif endoluminal selon la revendication 7, où il n'y a pas de contact entre des parties rectilignes (22) adjacentes de boucles (68) adjacentes.
  9. Dispositif endoluminal selon la revendication 7, où le second fil (16") s'étend dans une seconde direction hélicoïdale dans la région moyenne (30) et passe dans la partie rectiligne (22) qui s'étend dans la direction axiale dans la région d'extrémité distale (40).
  10. Dispositif endoluminal selon la revendication 9, où le second fil (16") passe en outre de la direction axiale dans la région d'extrémité distale (40) à une première direction hélicoïdale par l'intermédiaire d'une région de flexion distale.
  11. Dispositif endoluminal selon l'une quelconque des revendications 7-10, où la boucle (68) est complétée par le premier fil (16') joint au second fil (16") au niveau d'une région de jonction.
  12. Dispositif endoluminal selon la revendication 1, où le stent (12) est construit à partir du au moins un fil (16), le au moins un fil (16) formant un motif de tresse de région moyenne dans la région moyenne (30), où le au moins un fil (16) définit un angle de tresse de région moyenne (α); et un motif de tresse de région d'extrémité distale dans la région d'extrémité distale (40), où le au moins un fil (16) définit un angle de tresse de région d'extrémité distale (α', α"), l'angle de tresse de région moyenne (α) ayant une valeur plus grande que celle de l'angle de tresse de région d'extrémité distale (α', α") dans au moins un état de repos.
  13. Dispositif endoluminal selon l'une quelconque des revendications précédentes, où la région d'extrémité distale (40) du dispositif endoluminal est plus flexible que la région moyenne (30) de sorte qu'une force de compression radiale dans une configuration de diamètre réduit au niveau de la région d'extrémité distale (40) est plus basse que celle au niveau de la région moyenne (30).
  14. Dispositif endoluminal selon la revendication 13, où la région d'extrémité distale (40) du dispositif endoluminal est plus flexible que la région moyenne (30) de sorte que la force de compression radiale dans la configuration de diamètre réduit au niveau de la région d'extrémité distale (40) est plus basse qu'environ deux tiers de celle au niveau de la région moyenne (30).
  15. Dispositif endoluminal selon la revendication 1, où le au moins un fil (16) inclut une pluralité de fils formant la pluralité de boucles (68), où les parties rectilignes (22) se terminent par la flexion d'un fil pour joindre un fil adjacent au niveau d'une région de jonction.
EP14805717.7A 2013-11-08 2014-11-05 Dispositif endoluminal Active EP3065675B1 (fr)

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JP2018043060A (ja) 2018-03-22
JP6568925B2 (ja) 2019-08-28
CN110063825A (zh) 2019-07-30
CN105873547A (zh) 2016-08-17
US20190015230A1 (en) 2019-01-17
EP3065675A1 (fr) 2016-09-14
ES2950893T3 (es) 2023-10-16
US20150134074A1 (en) 2015-05-14
US20240277497A1 (en) 2024-08-22
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US11096806B2 (en) 2021-08-24
US20160175126A1 (en) 2016-06-23
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US10085861B2 (en) 2018-10-02
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JP6266774B2 (ja) 2018-01-24
CN110063825B (zh) 2021-09-14
WO2015069782A1 (fr) 2015-05-14
JP2016535641A (ja) 2016-11-17
US11998463B2 (en) 2024-06-04
CN105873547B (zh) 2019-05-03
US20210353444A1 (en) 2021-11-18

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